Brown Adipose Tissue Activation by Spinal Cord Stimulation

Purpose

The objective of this study is to investigate and utilize spinal cord stimulation (SCS) as an effective approach to eliciting weight loss and potentially alleviating Type 2 diabetes mellitus (DM), as evidenced by increasing metabolism of adipose tissue.

Conditions

  • Pain, Back
  • Obesity, Morbid
  • Type 2 Diabetes

Eligibility

Eligible Ages
Between 21 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age: 21-70 years 2. Persistent neuropathic leg and back pain 3. Subjects who are already planning to undergo SCS for pain 4. Subjects who have not received a prior SCS trial for pain 5. Subjects with a BMI of 25-45, using formula; weight (lb) / [height (in)]2 x 703

Exclusion Criteria

  1. Not considering SCS for pain 2. Forensic patient 3. Taking beta blockers 4. Weight change > 5% within last 3 months 5. Habitual tobacco use 6. Habitual excessive alcohol use 7. Pregnancy 8. Decisionally impaired adults 9. Children 10. Neonates 11. Subjects with a BMI of <25 or >45

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
All subjects 		All subjects will have two PET/CT scans on days 3 and 5 after SCS electrode implantation: (1) Baseline and (2) SCS-activated. Other than SCS activation, both studies will be conducted under identical conditions. For the first scan, subjects will be randomly assigned to either a baseline (no SCS during PET/CT) or with SCS during PET/CT prior to the day of their first scan. The second scan will complete the sequence with either a baseline or SCS-activated scan, as randomized.
  • Device: Research electrode
    A second electrode will be placed percutaneously by Tuohy needle in the epidural space at the same time as the SCS trial implant; at lateral T1-2 area randomly assigned to the left or right side of the lateral epidural space, at the time of the procedure. Placement of electrodes is not experimental, but the placement of a second electrode is a research-driven procedure.

Recruiting Locations

Oregon Health & Science University
Portland, Oregon 97239
Contact:
Kim Burchiel, MD
503-494-4314

More Details

Status
Recruiting
Sponsor
Oregon Health and Science University

Study Contact

Kim Burchiel, MD
503-494-4314
burchiek@ohsu.edu

Detailed Description

This research study aims to investigate possible activation of brown adipose tissue (BAT) metabolism by upper thoracic spinal cord stimulation (SCS). We believe that our multidisciplinary research team presents a unique opportunity to test whether SCS can activate BAT metabolism, as tested during a routine screening procedure for spinal cord stimulation (SCS) for pain control. Our marker for BAT activation is 18F-fluorodeoxyglucose (FDG) - positron emission tomography (PET), which has previously been used to gauge cold-evoked BAT activation, and other studies of BAT in humans. We believe this proof-of-concept study could pave the way for a new therapeutic modality for the treatment of morbid obesity, and Type 2 Diabetes Mellitus.